BEDFORD, Mass.--(BUSINESS WIRE)--Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced multiple scientific presentations at the American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting being held November 13 -15, 2020.
“We are presenting two posters and a paper at this year’s American Academy of Ophthalmology (AAO) that continue to highlight Ocular Therapeutix’s differentiated ophthalmology programs, including real world data on DEXTENZA® and new clinical data in OTX-TKI,” said Michael Goldstein, MD, MBA, Chief Medical Officer of Ocular Therapeutix. “We are particularly encouraged with new interim Phase 1 data in OTX-TKI that supports the products safety profile and demonstrates evidence of biological activity in patients with wet AMD across all three dose groups. Overall, we are thrilled with the progress we have seen in both DEXTENZA and OTX-TKI and look forward to providing additional updates on all the programs being developed with our novel hydrogel platform.”
Presentations at AAO:
Safety and Biological Activity of Intravitreal OTX-TKI Implant in Neovascular Age-Related Macular Degeneration (nAMD) – Phase 1 Study. D Boyer
Interim data from the Phase 1 study continues to demonstrate that OTX-TKI has been generally well tolerated with a favorable safety profile. Evidence of biological activity is demonstrated across the three dose groups as measured by a decrease in subretinal and/or intraretinal fluid. Durability has been seen up to 11 months in one subject without the need to rescue.
Magnitude of Cumulative Drug Effect and Time to Resolution with an Intracanalicular Dexamethasone Insert (0.4 mg) in Pooled Phase 3 Studies. F Mah
Data being presented continues to support DEXTENZA’s rapid and consistent efficacy in the treatment of post-cataract inflammation and pain.
Real World Patient Experience with Dropless Steroid Therapy using a Novel Hydrogel Based Intracanalicular Dexamethasone (0.4 mg) Insert. P Majmudar
Data from this Phase 4 real world, clinical trial demonstrates subjects undergoing cataract surgery reported high satisfaction and preference for DEXTENZA over topical drops, irrespective of administration in the operating room or outpatient clinical setting. Data collected outside conventional randomized clinical trials provides insights into adapting a novel sustained release steroid therapy into routine clinical practice.
In addition, two posters will be presented on DEXTENZA from two of the investigator-initiated trials.
- Dropless Punctal Plug Dexamethasone, Intracameral Ketorolac and Moxifloxacin Compared to Conventional Topical Therapy in Cataract Surgery. Donnenfeld/Hovanesian
- Intracanalicular Dexamethasone Insert vs. Topical Steroid for the Treatment of Pain and Inflammation Following Bilateral LASIK Surgery. Greenwood
All virtual presentations will be available for those registered starting November 11, 2020, by accessing the American Academy of Ophthalmology’s 2020 Virtual Media Guide.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix’s first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. Ocular Therapeutix’s earlier stage development assets currently in Phase 1 clinical trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension and OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases. Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease in a Phase 2 clinical trial. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is an FDA-approved device to seal corneal incisions following cataract surgery.
Forward Looking Statements
Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company’s product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company’s product candidates, such as the Company’s development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-CSI for the chronic treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company’s extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company’s product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company’s cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company’s scientific approach and general development progress, the availability or commercial potential of the Company’s product candidates, the Company’s ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company’s existing indebtedness, the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company’s ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company’s and relevant regulatory authorities’ operations, the need for additional financing or other actions and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.